This phase II trial studies how well fluorine F 18 fluoro furanyl norprogesterone (FFNP) positron emission tomography (PET)/magnetic resonance imaging (MRI) works in diagnosing breast cancer. Diagnostic procedures, such as PET/MRI with fluorine F 18 fluoro furanyl norprogesterone, may help find and determine if breast cancers are progesterone receptor positive or negative.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03212170.
PRIMARY OBJECTIVE:
I. To compare FFNP uptake of biopsy-proven primary progesterone receptor (PR)+ breast malignancies measured using PET/MRI with the reference standard of PR immunohistochemistry (IHC).
SECONDARY OBJECTIVES:
I. To determine the test-retest reproducibility of quantitative assessment of tumor FFNP uptake.
II. To determine the intra- and inter-observer variability of quantitative assessment of tumor FFNP.
III. To evaluate the optimal cut-point of FFNP uptake for distinguishing between PR-negative and PR-positive invasive breast cancer.
IV. Estimate the association of tumor FFNP uptake (continuous standardized uptake value maximum [SUVmax]) with research-based Oncotype DX scores (0-100).
EXPLORATORY OBJECTIVES:
I. To evaluate heterogeneity of tumor FFNP uptake.
II. To correlate tumor FFNP uptake with serum progesterone and estradiol levels.
III. To correlate tumor FFNP uptake with disease recurrence.
OUTLINE:
Patients receive FFNP intravenously (IV) over 2 minutes. Beginning 60 minutes after FFNP administration, patients undergo PET/MRI scan over 30-40 minutes.
After completion of study, patients are followed up within 1-3 days.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorAmy Marie Fowler
